ANSI AAMI ISO 13408-7-2012 (R2018)

Category: Technical

Posted on 2020-09-14, by banz.


Aseptic Processing Of Health Care Products — Part 7: Alternative Processes For Medical Devices And Combination Products Specifies the requirements for, and offers guidance on, processes, programs and procedures for procurement, development, validation, routine control of the manufacturing process and transport for aseptically processed cell based medical products (CBMP), especially tissue engineering products (TEP´s) whose biological properties have to be kept intact to maintain their efficacy as a medical device and/or medicinal product.

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